Lanreotide Autogel in the Treatment of Symptomatic Polycystic Liver Disease
NCT ID: NCT01315795
Last Updated: 2014-07-08
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2/PHASE3
59 participants
INTERVENTIONAL
2011-03-31
2014-07-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Symptomatic polycystic liver disease (PCLD) patients
Symptomatic polycystic liver disease (PCLD) patients
Lanreotide Autogel 90 mg and 120 mg
administration of lanreotide sc every 4 weeks (28 days)
Interventions
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Lanreotide Autogel 90 mg and 120 mg
administration of lanreotide sc every 4 weeks (28 days)
Eligibility Criteria
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Inclusion Criteria
* ≥ 20 liver cysts
* Symptomatic patients defined as at least 2 out of 5 of the following symptoms related to mass effect irrespective of the intensity:
* Abdominal distention perceived as uncomfortable
* Frequent abdominal pain
* Early satiety
* Nausea (with the inclusion of dyspeptic complaints)
* Dyspnea
* Diagnosed with ADPKD or ADPLD
* Male and female patients of 18 years and older
* Written informed consent
Exclusion Criteria
* Patient who underwent a kidney transplant and received variable doses of immunosuppressive therapy and/or present signs of rejection in the past year
* Hormonal replacement therapy
* Hormonal contraception
* Pregnant or lactating
* Presenting with an uncontrolled disease (other than ADPKD/ADPLD)
* Planned to undergo any surgery of the liver during study participation
* Planned to undergo any surgery of the KIDNEY during study participation (ADPKD patients only)
* Patients with known allergies to somatostatin or its analogues or any of its components
* Patients who received somatostatin analogues in the 6 months preceding study inclusion
18 Years
ALL
No
Sponsors
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Ipsen
INDUSTRY
Universitaire Ziekenhuizen KU Leuven
OTHER
Responsible Party
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Dr Frederik Temmerman
Professor Dr Frederik Nevens
Principal Investigators
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Frederik Nevens, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
UZ Leuven, Gasthuisberg
Locations
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UZ Leuven, Gasthuisberg
Leuven, Provincie Vlaams-Brabant, Belgium
Countries
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References
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van Keimpema L, Nevens F, Vanslembrouck R, van Oijen MG, Hoffmann AL, Dekker HM, de Man RA, Drenth JP. Lanreotide reduces the volume of polycystic liver: a randomized, double-blind, placebo-controlled trial. Gastroenterology. 2009 Nov;137(5):1661-8.e1-2. doi: 10.1053/j.gastro.2009.07.052. Epub 2009 Jul 29.
Temmerman F, Ho TA, Vanslembrouck R, Coudyzer W, Billen J, Dobbels F, van Pelt J, Bammens B, Pirson Y, Nevens F. Lanreotide Reduces Liver Volume, But Might Not Improve Muscle Wasting or Weight Loss, in Patients With Symptomatic Polycystic Liver Disease. Clin Gastroenterol Hepatol. 2015 Dec;13(13):2353-9.e1. doi: 10.1016/j.cgh.2015.05.039. Epub 2015 Jun 12.
Related Links
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Lanreotide reduces the volume of polycystic liver: a randomized, double-blind, placebo-controlled trial.
Other Identifiers
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2010-024604-10
Identifier Type: -
Identifier Source: org_study_id
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